EMPOWER Intervention for Young Adult Cancer Survivors

(MOST EMPOWER Trial)

No longer recruiting at 2 trial locations

Overseen By Vivian McAllister, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Psychiatric hospitalization, Palliative care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a digital health tool called the EMPOWER Intervention, designed to enhance the well-being of young adults who have survived cancer. The study aims to understand how activities like mindfulness, diet, and mood management can improve overall quality of life and coping skills. Participants will join different groups to try various strategies, such as focusing on positive events, managing weight, and learning financial skills. Anyone who has had cancer, except for basal cell skin cancer, and completed treatment within the last five years may qualify, provided they have internet access and are not receiving current psychiatric or hospice care.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve the quality of life for cancer survivors.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that maintenance therapy for certain cancers is not considered active treatment, so you might not need to stop those.

What prior data suggests that the EMPOWER Intervention is safe for young adult cancer survivors?

Research has shown that the EMPOWER program has been used in various studies to improve mental well-being. The program includes online sessions that teach skills for managing stress, boosting mood, and dealing with challenging thoughts.

Previous studies of EMPOWER have not reported any major safety issues. Since it focuses on techniques for changing thought patterns and mindfulness, it is generally considered safe. Participants in earlier trials did not experience significant negative side effects.

Overall, early findings suggest that EMPOWER is well-tolerated by participants and can be a helpful tool for improving mental health. Those considering joining this trial can find reassurance in past studies showing its safety for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPOWER intervention for young adult cancer survivors because it offers a holistic approach to post-cancer care, addressing both mental and physical aspects of recovery. Unlike traditional treatments that might focus solely on cancer's physical aftermath, EMPOWER combines cognitive support, mindfulness, and lifestyle changes like diet and weight management. It also uniquely includes components such as financial literacy and positive psychology, aiming to enhance overall well-being and resilience. This comprehensive method could lead to more sustainable and positive outcomes for young survivors, making it a promising advancement in cancer survivorship care.

What evidence suggests that this trial's treatments could be effective for young adult cancer survivors?

Studies have shown that the EMPOWER program can enhance well-being and quality of life for young adult cancer survivors. This trial will examine various aspects of the EMPOWER intervention, with different treatment arms focusing on components like mindfulness, positive thinking, and goal-setting. Research indicates that this online program fosters positive feelings and teaches coping strategies. Initial findings suggest that participants feel less stressed and more in control of their emotions after using EMPOWER. Previous users reported feeling happier and more relaxed. Overall, evidence suggests that EMPOWER could be a valuable tool for improving life quality among cancer survivors. ^{2 6 7 8 9}

Who Is on the Research Team?

John M. Salsman, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for young adult cancer survivors, aged 15-39, who were diagnosed with their first cancer at the same age range and are within 0-5 years post-active treatment. Participants must understand English and have internet access. Those hospitalized for psychiatric illness or in palliative/hospice care cannot join.

Inclusion Criteria

Able to read and understand English

I finished my cancer treatment less than 5 years ago, not counting maintenance or hormonal therapy.

Internet access through a home computer, tablet or smartphone

Exclusion Criteria

I am currently receiving care to ease symptoms, not cure my disease.

Ever been hospitalized for a psychiatric illness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the EMPOWER digital health intervention, which includes components such as mindfulness, positive reappraisal, and focusing on personal strengths.

4 months

Follow-up

Participants are monitored for changes in positive affect, life satisfaction, depression, and anxiety after the intervention.

4 months

What Are the Treatments Tested in This Trial?

Interventions

• EMPOWER

Trial Overview The EMPOWER digital health intervention is being tested to see if it can improve well-being, coping skills, and mood management among young adult cancer survivors. The study aims to enhance overall wellness and quality of life through this online program.

How Is the Trial Designed?

Group I: Condition 9 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection

Group II: Condition 8 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group III: Condition 7 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection

Group IV: Condition 6 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Group V: Condition 5 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group VI: Condition 4 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group VII: Condition 32 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group VIII: Condition 31 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection

Group IX: Condition 30 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Group X: Condition 3 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XI: Condition 29 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group XII: Condition 28 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Strengths/Achievable Goals and 5) Acts of Kindness

Group XIII: Condition 27 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XIV: Condition 26 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Group XV: Condition 25 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XVI: Condition 24 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XVII: Condition 23 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group XVIII: Condition 22 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Group XIX: Condition 21 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group XX: Condition 20 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XXI: Condition 2 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Group XXII: Condition 19 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XXIII: Condition 18 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Group XXIV: Condition 17 Experimental Treatment 1 Intervention

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection

Group XXV: Condition 16 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XXVI: Condition 15 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XXVII: Condition 14 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Group XXVIII: Condition 13 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Group XXIX: Condition 12 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Group XXX: Condition 11 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Group XXXI: Condition 10 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Group XXXII: Condition 1 Experimental Treatment 1 Intervention

1\) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36890329/

An eHealth, Positive Emotion Skills Intervention for Enhancing ... We developed an eHealth positive emotion skills intervention for post-treatment survivors called EMPOWER (Enhancing Management of Psychological Outcomes With ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT03276559/Prot_SAP_001.pdf

Enhancing & Mobilizing the Potential for Wellness & ... Examine the effects of EMPOWER on patient outcomes, including intensity of care and quality of life/quality of. Page 6. Enhancing & Mobilizing the Potential for ...

3. researchgate.net researchgate.net/publication/369099664_An_eHealth_Positive_Emotion_Skills_Intervention_for_Enhancing_Psychological_Well-Being_in_Young_Adult_Cancer_Survivors_Results_from_a_Multi-Site_Pilot_Feasibility_Trial

An eHealth, Positive Emotion Skills Intervention for ... A Systematic Review of Health-related Quality of Life Outcomes in Psychosocial Intervention Trials for Adolescent and Young Adult Cancer Survivors. Article.

4. healthcaredelivery.cancer.gov healthcaredelivery.cancer.gov/funding/sample_grants/FINAL%20-%201R01CA242849-01.pdf

Optimizing an Emotion Regulation Intervention to Enhance Well Pilot testing of an online intervention to enhance psychological well-being in young adult cancer survivors: The EMPOWER trial. . Annual Conference of the ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392424006584

EMPOWER: A Multi-Site Pilot Trial to Reduce Distress in ... The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of EMPOWER (Enhancing and Mobilizing the POtential for Wellness ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6617585/

Enhancing & Mobilizing the POtential for Wellness & ... The EMPOWER intervention targets symptoms of peritraumatic stress and anticipatory grief that may interfere with optimal decision-making on the ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/?otool=iaufhhslib&term=39710338

Design and methods of the EMPOWER full factorial trial EMPOWER is a five-session online intervention that teaches behavioral and cognitive skills for increasing psychological well-being.

8. endoflife.weill.cornell.edu endoflife.weill.cornell.edu/research/enhancing-and-mobilizing-potential-wellness-and-emotional-resilience

Enhancing and Mobilizing the Potential for Wellness and ... EMPOWER is a cognitive-behavioral, acceptance-based intervention delivered by a trained social worker to informal caregivers in the ICU.

9. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-06081

Enhancing & Mobilizing the POtential for Wellness & ... EMPOWER is a cognitive-behavioral, acceptance-based intervention for patient surrogate decision-makers to reduce experiential avoidance of unpleasant thoughts ...